Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

• ClinicalTrials.gov Identifier: NCT02716415
• Recruitment Status: Completed
• First Posted: March 23, 2016
• Last Update Posted: April 24, 2020
• Sponsor: University of the Philippines
• Collaborator: Calmoseptine, Inc.
• Information provided by (Responsible Party): University of the Philippines

Tracking Information

• First Submitted Date: February 24, 2016
• First Posted Date: March 23, 2016
• Last Update Posted Date: April 24, 2020
• Study Start Date: March 2015
• Actual Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 22, 2016)

Healing of diaper Dermatitis [ Time Frame: Assessed on Final day of data collection (Day 6) ]

Complete healing of Diaper Dermatitis on final study day, as determined by Diaper Dermatitis Severity Scale. Possible score range from zero (0 - clear skin) ti six (6 - severe erythema, all or most of the diaper area affected, with papules and/or pustules, and open skin affecting the dermis). Complete healing is defined as a Diaper Dermatitis Severity Score of zero (0). Assessment of the primary outcome used in final analyses will be blinded. For determination of final trial results for the primary outcome, sets of high definition photographs for each patient on each treatment day will be assessed by independent wound, Ostomy and Continence Nursing Certification Board (WOCNB) certified wound care expert assessors based in the USA, who are blinded to treatment allocation, not involved in the study.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 22, 2016)

Daily Diaper Dermatitis Severity Score [ Time Frame: Assessed on Day 0, 1, 2, 3, 4, 5, and 6 ]

Diaper dermatitis severity, assessed as per primary outcome. The size of area affected by diaper dermatitis is measured and recorded at baseline (study entry on Day 0) and on each follow up day (Days 1-6). Disposable paper tape measures are used to prevent cross-infection. Where more than one non-contiguous area is affected, each will be measured as described and added together. As the study will include neonates and infants up to one year of age, body size will differ significantly so that an affected area of a similar size may be more serious in one participant than in another. Accordingly, the mean body size and/or weight of treatment groups will be considered and the expression of area affected used in final analyses will be adjusted appropriately.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 22, 2016)

• Size of area affected by diaper dermatitis on Days 0-6. [ Time Frame: Measured on Day 0, 1, 2, 3, 4, 5, and 6 ]
  The area will be calculated by multiplying the longest portion of the affected area measured in a head to toe orientation by the widest portion of the affected area measured from side to side (in centimeters).
• Adverse Events. [ Time Frame: Recorder on Day 0, 1, 2, 3, 4, 5, and 6 ]
  Non-Serious and serious adverse events judged by physicians to be due to trial participation.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
• Official Title: Randomized Controlled Trial Comparing the Efficacy and Safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants
• Brief Summary: The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.

Detailed Description

This is a single-center, randomized, controlled, assessor-blinded clinical trial. Neonates born in UP-PGH or infants (< 1 year of age) in the general pediatric wards for any condition who have diaper dermatitis are recruited and randomized to treatment with either Calmoseptine Ointment or Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste as part of a structured skin care regimen. Each participant has one week total participation, unless withdrawn. Baseline data are collected and study treatment initiated on study entry day. Treatment continued and follow up data collected on six subsequent follow up days. Primary outcome: healing of Diaper Dermatitis after six days of treatment, defined as a Diaper Dermatitis Severity Score of zero attributed by blinded assessment. Secondary outcomes: Diaper Dermatitis Severity Score at each day of treatment; size of affected area; incidence of Candida infection; adverse events.

Zinc Oxide Ointment preparations including Calmoseptine Ointment and Desitin Maximum Strength 40% Diaper Rash Paste have been used to treat diaper dermatitis for many years around the world. There are no known reported hypersensitivities to either product and no reported serious adverse events. As the proposed study is in neonates and infants, as a precaution the evidence relating to the safety and toxicity of individual ingredients were reviewed for the trial protocol prior to commencement.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Diaper Dermatitis

Intervention

• Drug: Calmoseptine Ointment

  A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered.

  The regimen includes:

  • regular diaper changing,
  • gentle cleansing
  • application of the trial ointment
  Other Name: Calmoseptine
• Drug: Destin Maximum Strength 40% Zinc

  A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered.

  The regimen includes:

  • regular diaper changing,
  • gentle cleansing
  • application of the trial ointment
  Other Name: Destin

Study Arms

• Active Comparator: Calmoseptine Ointment
  Calmoseptine Ointment as part of a structured skin care regimen.
  Intervention: Drug: Calmoseptine Ointment
• Active Comparator: Destin Maximum Strength 40% Zinc
  Destin Maximum Strength 40% Zinc as part of a structured skin care regimen.
  Intervention: Drug: Destin Maximum Strength 40% Zinc

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 21, 2020): 319
• Original Estimated Enrollment (submitted: March 22, 2016): 326
• Actual Study Completion Date: March 31, 2018
• Actual Primary Completion Date: March 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. The child participant must be < 1 year of age.
2. The participant must, upon clinical inspection by an investigator, be assessed to have diaper dermatitis ≥ Grade 2 according to the study's diaper dermatitis severity scale (see "Primary Outcome").
3. The participant's parent, next of kin or legally acceptable representative agrees to the child's inclusion and signs the informed consent.
4. The participant's primary physician agrees to inclusion.
5. There is a reasonable expectation that the participant will be hospitalized for at least 7 days and will be able to complete the study. (NB Study Participant Withdrawal Criteria b - Any participants discharged from hospital by their attending physician before completion of study participation will automatically be withdrawn from the study. Study participation will not under any circumstances lead to delay in a participant's discharge from hospital.)
6. Participant has no known allergy or history of adverse reaction to any of the ingredients in either product or to any topical preparations or skin care products

Exclusion Criteria:

1. Participants with a pre-existing full thickness wound within the study area.
2. Participants with pre-existing active dermatological condition(s), other than DD, which may affect healing or interpretation of trial results. Where uncertainty exists, the Investigators will arrange a consultation with a Consultant Dermatologist.
3. Participant has a history of recurrent dermatological conditions, other than DD, that may imply difficult healing or affect interpretation of trial results.
4. Participant has any severe acute or chronic medical condition such that trial participation may constitute a risk, or may interfere with their medical care, or affect interpretation of results, or their attending physician advises against participation.
5. Participant is on systemic antifungal treatment (eg. Amphotericin B or Fluconazole), topical antifungal treatment and / or systemic or topical corticosteroids.
6. Participant has in the preceding week been treated with topical agents that may affect healing (e.g. dimethicone based ointments, zinc oxide powder, petroleum jelly)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Day to 12 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Philippines

Administrative Information

• NCT Number: NCT02716415
• Other Study ID Numbers: 2015-019-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of the Philippines
• Original Responsible Party: Same as current
• Current Study Sponsor: University of the Philippines
• Original Study Sponsor: Same as current
• Collaborators: Calmoseptine, Inc.

Investigators

• Principal Investigator: Jacinto Blas Mantaring, MD; Department of Pediatrics, Philippine General Hospital UP Manila

• PRS Account: University of the Philippines
• Verification Date: April 2020